kidney transplantation
Conditions
Interventions
Trade Name: Prograft
Product Name: Prograft
Pharmaceutical Form: Capsule
Trade Name: Modigraf
Product Name: Modigraf
Ph
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Age 2-18 years old • Patients to be transplanted with a first kidney allograft • Patients receiving a kidney from a blood group AB0-compatible donor • Patients who will receive tacrolimus as part of the initial immunosuppressive therapy Are the trial subjects under 18? yes Number of subjects for this age range: 28 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • No signed written informed consent. • Recipients of a non-renal organ transplant at the same occasion • Recipients of a blood group AB0-incompatible kidney allograft • Recipients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days. • Recipients using medication known to have a pharmacokinetic interaction with tacrolimus (clarithromycin, doxycycline, erythromycin, rifampicin, carbamazepine, phenobarbital, phenytoin, amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, HIV protease inhibitors and theophylline).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on day 3 after transplantation by basing the starting dose of tacrolimus on a new dosing algorithm, rather than the standard bodyweight-only-based approach.; Secondary Objective: • Whether a tacrolimus starting dose based on the algorithm will lead to more patients being within the tacrolimus target C0 on days 7 and 10 after transplantation compared with previously transplanted patients receiving a standard starting dose of tacrolimus. • Whether a tacrolimus starting dose based on the algorithm will lead to fewer patients with extremely high or low tacrolimus C0 on day 3 after transplantation • Whether a tacrolimus starting dose based on the algorithm will lead to a more rapid achievement of tacrolimus target C0 • Whether a tacrolimus starting dose based on the algorithm will lead to a different cumulative tacrolimus dose (mg/kg/day) • Incidence of BPAR and (serious) adverse events within the first 10 days after transplantation. ;Primary end point(s): The main study endpoint of the study is the proportion of patients reaching the target C0 (10-15 ng/mL) on day 3.;Timepoint(s) of evaluation of this end point: 3 days after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3, 7 and 10 days after transplantation; Secondary end point(s): Secondary study endpoints of the study are: • The proportion of patients reaching the target C0 on day 7 and 10. • The proportion of patients with markedly supra- (>20 ng/mL) or sub-therapeutic (<5 ng/mL) tacrolimus C0 on day 3 after transplantation. • The time to reach the target C0 (10-15 ng/mL). • Incidence of biopsy proven acute rejection and (serious) adverse events within the first 10 days after transplantation. | — |
Countries
Netherlands
Contacts
Public ContactPediatric Nephrology
Erasmus MC
Outcome results
None listed